Adeza Gestiva NDA for preterm birth
This article was originally published in Pharmaceutical Approvals Monthly
Adeza is requesting a priority review of its Gestiva (17 alpha-hydroxyprogesterone caproate) NDA for prevention of preterm birth in women with a history of preterm delivery, the firm says May 4. The NDA is based on a study conducted by the National Institutes of Health. Gestiva is a long-acting, naturally occurring form of progesterone. "If Gestiva is approved, Adeza will have the only commercially available, NIH-studied, ACOG-recommended" treatment for the indication, Adeza said...
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